Project Manager overseeing clinical research projects, site activities, and vendor delivery at Indero, a clinical-trials CRO. Coordinating budgets, timelines, compliance, and stakeholders.
Responsibilities
Ensure successful initiation, planning, execution, monitoring, controlling, and closure of assigned clinical research projects
Serve as a primary contact for Sponsors, vendors, and internal teams
Coordinate tasks and deadlines across departments
Oversee project coordinators, SSU team members, RDA, and RAC resources for site activation prioritization
Coordinate vendor supplies and services with site activation timelines
Escalate at-risk site activation timelines to Project Manager II
Manage stakeholder needs and expectations and support team training
Plan project activities and resources and manage work and deliverable quality
Provide project status updates and reconcile study trackers
Analyze discrepancies and support corrective actions, change control, and risk management
Review and assist in drafting operational plans, processes, and manuals
Ensure study documents and deliverables meet applicable country, regulatory, SOP, GCP, and study-specific requirements
Oversee site selection, patient recruitment, investigator meetings, regulatory submissions, essential documents, TMF reviews, and clinical monitoring support
Maintain project training matrices and ensure team training completion
Support sites with investigational products, study supplies, equipment, and safety lab kits
Collaborate with Data Management on CRF compliance, query resolution, data review, and database lock timelines
Oversee vendors throughout the project lifecycle and monitor services, performance, milestones, risks, issues, deviations, quality events, documentation, metrics, and KPIs
Review vendor work orders, budgets, scopes of work, change orders, and invoices
Lead or participate in vendor meetings and ensure resolution of follow-up actions
Collaborate with subject matter experts and Quality Assurance to ensure vendor deliverables and quality requirements are met
Maintain positive vendor relationships and vendor compliance with contractual obligations
Requirements
B.Sc. in a related field of study to clinical research
At least 3 years of experience in a similar role, including management of clinical studies in the pharmaceutical, biotechnology and/or CRO industry
At least 2 years of experience coordinating clinical trial management activities
Excellent knowledge of GCP and ICH standards, FDA and Canadian regulations
Excellent knowledge of Microsoft Office suite
Excellent oral and written skills in English; French is an asset
Experience managing small to medium projects using a disciplined approach to project management
Demonstrated ability to establish and deliver resource-based project plans
Experience working with and managing teams in a matrix environment
Excellent communication, people management, problem-solving, organizational, teamwork, and pressure-management skills
Legally authorized to work in Canada
Benefits
Flexible work schedule
Permanent full-time position
Comprehensive benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities)
Ongoing learning and development opportunities
Option to work remotely anywhere in Canada or from the Montreal headquarters
Occasional visits to the Montreal office may be required or encouraged
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